Clinical Trials Medical Writer in ROCHESTER, New York at Rochester Regional Health

Department: Study Set Up

Location: Remote | United States

Hours Per Week: 40 hours

Schedule: Days, Monday – Friday

SUMMARY

The Medical Writer is responsible for interpreting complex clinical study protocols and other medical/scientific documentation to prepare and coordinate laboratory specification and studyspecific medical/technical documents for ACM Global Laboratories. They will partner with internal departments in the development, drafting, review, editing, and finalization of documents used to conduct clinical studies.

RESPONSIBILITIES

• Lead the development, revision, and maintenance of complex clinical study and amendments in accordance to standard operating procedures (SOPs) and regulatory requirements.

• With support of a mentor, work on the development, revision, and maintenance of high profile and expedited complex study documents and amendments in accordance to SOPs and regulatory requirements.

• Responsible for authoring and finalizing global lab specification documents (GLSD) and other related documents, as needed.

• Interpret, understand, and contribute to the scientific details of the protocol/technical documentation; identify and resolve gaps to ensure client satisfaction.

• Serve as a subject-matter expert (SME) for medical documentation utilized throughout the study lifecycle.

• Lead, initiate, and manage multiple rounds of internal and external document review.

• Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meet high quality standards and aligns with business process.

• Participate in client interactions during study start-up activities and/or during study amendment process.

• Review of low to medium complexity GLSD in accordance to SOPs and Quality Assurance processes.

• With support of a mentor, work on the review of high complexity GLSD in accordance with SOPs and Quality Assurance processes.

• Lead the development, revision, and maintenance of lab manuals in accordance to SOPs and regulatory requirements.

• Review lab manuals to ensure alignment with SOPs and Quality Assurance processes.

• Resolve challenges and build consensus between all cross-functional groups and collaborators in a timely manner.

• Maintain a general working knowledge of Food & Drug Administration (FDA), Medical & Healthcare Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical Practice (GCP), ICH and other pertinent regulations.

• Demonstrate initiative in professional self-development to improve job performance to maintain relevant working knowledge of clinical trials.

• Resolve queries for complex studies by using knowledge of regional differences and internal ACM processes for low and medium complexity GLSD and understanding of department responsibilities.

• Perform other duties and/or tasks as assigned.

REQUIRED QUALIFICATIONS

• BA/BS, or equivalent experience in scientific field

• 1 yrs clinical trials or other laboratory experience required

PREFERRED QUALIFICATIONS

• Applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, regulatory guidance documents, and templates

• Proficient in Microsoft Office and desktop publishing or word processing

• Education in medical or technical writing

• Excellent communication skills

• Ability to effectively influence others, work in a team environment, and collaborate across lines of business and functions

• 1+ years’ experience drafting clinical trials documentation